Device and method for irreversible closure of fluid communication in a container system

ABSTRACT

A biological fluid collection system including a collecting device, a collecting container, a first channel connecting the two, a sampling bag, a second channel connecting the sampling bag and the first tube and at least one substantially irreversible closure device in an open position on at least the first or second channel. The biological fluid may be blood. A method of collecting biological fluid such as blood using the system so that fluid in the sampling bag is substantially irreversibly prevented from entering the collecting container.

FIELD OF THE INVENTION

The invention concerns a container system including a container for abiological fluid, a channel, and at least one device for substantiallyirreversible closure of fluid communication within the system. Theinvention also includes methods of using the system including a methodof collecting blood using such a system.

BACKGROUND OF THE INVENTION

Current container systems make it possible to collect blood from a donoror otherwise collect biological fluid. Such systems often include acollecting container, usually a bag, connected to a collecting device bya tube. In addition, the systems may include a sampling container,usually also a bag, intended to receive the first milliliters of bloodcollected. The sampling container is connected to the tube in such amanner that it is filled after the collecting container is filled.

Filling the sampling bag prior to filling the collecting bag has certainadvantages. First, it reduces the risk of contamination of the blood inthe collecting bag from bacteria or other foreign substances on the skinof the donor. The first milliliters of blood taken, which are morelikely to contain bacteria and foreign substances, are sent into thesampling bag rather than into the collecting bag. Second, use of asampling bag makes it possible to take samples before the sample orcollection bag is completely filled, and consequently not to waste time.Finally, during blood collection, the loss of blood volume for the donormay be compensated for by the addition of plasma. This causes themeasured hematocrit of the blood to be lower if the sampling bag isfilled, or samples are otherwise taken, after the collecting bag isfilled. Consequently, the hematocrit count obtained using such latercollected samples may be inaccurate.

After having collected the blood from a donor and before it istransfused into a patient, the blood contained in the sampling bag canbe systematically analyzed in order to determine the rhesus group, toeffect a hematocrit count and to detect any contamination such asviruses, bacteria or other elements foreign to the blood of the donor.

Although useful, these systems and methods as currently used forcollecting blood from a donor do have drawbacks. First, the fact thatthe closure device situated on the tube connected to the sampling bagcan be released could cause it to be opened by the user in order to sendthe blood remaining in the sampling bag to the collecting bag. This mayoccur by accident, or through deliberate action, for instance, if thecollecting bag is found to be insufficiently filled after disconnectionfrom the arm of the donor. Therefore the reversible closure of thesampling bag tube presents a significant risk of faulty use. This faultyuse may negate the contamination containment benefits of the samplingbag and may also lead to other problems.

Moreover, the reversible closure device situated on the tube connectingthe needle and the collecting bag does not provide a sufficient seal tobe able to dispense with a welder at the location where the blood iscollected. Blood collection, particularly at temporary locations, wouldbe more time and cost efficient if welding at the collection locationwere not required.

SUMMARY OF THE INVENTION

To mitigate these and other drawbacks, the invention includes acontainer system in which at least one channel connecting its differentcomponents is provided with a device for the substantially irreversibleclosure of fluid communication.

To this end, the invention includes in an exemplary embodiment acontainer system including a collecting container for a biological fluidsuch as blood or a blood component.

The collecting container and any other container in the system may be abag or system of bags, a rigid container, such as a centrifuge well orany other type of container. The collecting container may be selected toserve as a suitable storage container for the biological fluid. Theselection of the container may be influenced by the next processing stepafter collection or by the ultimate use of the biological fluid andother considerations apparent to one skilled in the art.

The collecting container is in fluid communication with a first channel.Such fluid communication may be established through direct connection ofthe first channel to an inlet/outlet orifice of the collecting containeror by any other type of direct or indirect connection known to the art.The first channel and any other channels in the collection system mayinclude a tube or system of tubes, Y joints and other joiningstructures, or any other device selected based on, inter alia thebiological fluid to be collected and its anticipated processing methodand uses.

A collecting device for collecting the biological fluid may be providedin fluid communication with the first channel and the collecting bag.The device for collecting the biological fluid may be a needle, a needleassembly, a pump, or another device selected based upon the fluid to becollected and its source or other considerations.

A sampling container is provided in fluid communication with a secondchannel that is also in fluid communication with the first channel. Thesampling container may be a bag, a system of bags, a rigid container orother type of container selected based on, inter alia, the biologicalfluid, the volume of samples needed, the methods of sampling, and anydevice used to obtain samples from the sampling container.

A substantially irreversible closure device is provided in or on atleast one of the first and second channel. The substantiallyirreversible closure device may include a locking structure and a flowprevention structure. The substantially irreversible closure device mayinclude a flange and a lock base. It may also be a clamp or a screw. Thesubstantially irreversible closure device may be selected so that, interalia, when the device is in a closed position, it is not readilyrestored to an open position without the use of some mechanical device,an unusual or unreasonable amount of force, or some destructive means.In a further example, the substantially irreversible closure device maynot be opened by a person of average strength using his or her handsalone.

A device for the reversible closure of the fluid communication may alsobe provided on the first channel. A sampling device may be associatedwith the sampling container. One exemplary sampling device is a vacuumtube adapter.

According to a second aspect, the invention includes a method ofcollecting blood using such a bag system in which the substantiallyirreversible closure devices are initially open. The method includes theinitial step of temporarily closing off the first channel using thereversible closure device. Next blood is collected from a donor in thesampling bag using the collecting device. Then the substantiallyirreversible closure device provided on the second channel is closed.Next fluid communication is opened in the first channel by maneuveringthe reversible closure device, allowing a collection bag to fill withthe collected blood. Finally, a substantially irreversible closuredevice provided on the first channel is closed.

According to a third aspect, the invention is directed to anirreversible closure device, which comprises a lock base including ahousing with two lateral clips to allow connection of the device to atube and at least two internal stops and an intermediate region betweenthe two internal stops and an orifice. The irreversible closure devicealso includes a flange comprising a projection that presses into theintermediate region between the two internal stops when the flange isclosed over the lock base and a finger with a radial toe. Theirreversible closure device further includes a hinge around which thelock base and flange rotate with respect to each other. The lock baseand flange may be rotated around the hinge to a closed position whereinthe finger is disposed within the orifice and is secured therein by theradial toe.

Technical advantages are readily apparent to one skilled in the art fromthe following figures, descriptions, and claims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a more complete understanding of the invention, and for furtherfeatures and advantages, reference is now made to the followingdescription, taken in conjunction with the accompanying drawings, inwhich:

FIG. 1 illustrates, in a perspective view, a device for the irreversibleclosure of fluid communication through a tube according to the presentinvention, the device being in the open position;

FIG. 2 illustrates, in schematic front view, a bag system according to afirst embodiment of the invention; and

FIG. 3 illustrates, in schematic front view, a bag system according to asecond embodiment of the invention.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS OF THE INVENTION

Exemplary embodiments of the present invention and their advantages arebest understood by reference to FIGS. 1 through 3, where like numbersare used to indicate like and corresponding features.

Referring to FIG. 1, an embodiment of a device 10 for the substantiallyirreversible closure of fluid communication through a channel, such astube 4 or tube 7 in FIGS. 2 and 3, is described (also referred to as an“irreversible closure device” to effect “irreversible closure”).

The irreversible closure device 10 comprises a lock base 12 and a flange13 mounted for rotation with respect to each other around a hinge 14,between an open position (shown in FIG. 1) and a closed position.

Lock base 12 and flange 13 can be produced from molded plastic material,for example polypropylene, which has the particular property of offeringgood resistance to steam or beta radiation/sterilization techniques.

Lock base 12 includes housing 15 intended to receive a tube portion.Housing 15 includes two lateral clips 15 a, 15 b. Clips 15 a and 15 bare designed so as to allow association of device 10 with a tube in amanner so that device 10, when open, does not substantially restrictfluid communication through the tube. Clips 15 a and 15 b areadditionally designed to assist in holding the tube when device 10 isclosed.

Flange 13 includes a projection 16 intended, when device 10 is in theclosed position, to crush the tube portion disposed in housing 15, so asto close fluid communication through the tube. For this purpose,projection 16 is provided on the internal face of flange 13 and has alength substantially equal to the depth of housing 15. In addition, thebottom of housing 15 is provided with two stops 15 c and 15 d which arespaced apart by substantially the width of projection 16 so as, onceprojection 16 is disposed between stops 15 c and 15 d, to improve theinterruption of fluid communication through the tube.

Lock base 12 and flange 13 include a mechanism for locking device 10 inthe closed position that cannot be released manually. For this purpose,lock base 12 includes a female locking mechanism formed by an orifice 17and flange 13 includes a male locking means formed by a finger 18provided with a radial toe 18 a which is intended to lock on a wall oforifice 17 when finger 18 is inserted therein. Thus, once toe 18 a isengaged, it is no longer readily possible to manually disengage finger18 from the inside of orifice 17.

Referring now to FIGS. 2 and 3, exemplary embodiments of a bag systeminclude a collecting bag 1 intended to contain a biological fluid.

In one example the biological fluid is blood or a blood component suchas in particular red cells, possibly concentrated and/or in suspension,blood platelets, possibly concentrated and/or in suspension, bloodplasma, possibly with a low or high platelet content.

FIGS. 2 and 3 depict a bag system forming a line for collecting bloodfrom a donor. For this purpose, the system includes a collecting deviceformed by a needle assembly 2 to be introduced into the vein of a donorand a needle guard 3, the collecting device being provided at one end ofa first tube 4 whose opposite end is connected to an inlet orifice 5 tocollecting bag 1. In addition the system includes a sampling bag 6 whichis connected by a second tube 7 and a Y junction 8 to first tube 4, anda lateral sampling device 9 associated with sampling bag 6 so as toenable samples to be removed by vacuum tubes.

In the embodiments depicted in the figures, first 4 and second 7 tubesare each provided with device 10 for irreversible closure of fluidcommunication. As a variation, and according to the specific constraintsof use of the system, such closure device 10 can be provided solely onone of tubes 4 or 7. In addition, it is also possible to replace otherreversible closure devices provided in this or other bag systems withirreversible closure device 10 according to the invention. The systemalso includes a device 11 for the reversible closure of fluidcommunication provided on first tube 4, between irreversible closuredevice 11 and Y junction 8.

Referring now to FIG. 3 alone, the system additionally includes a set ofbags intended to separate the different constituents of the collectedblood. To this end, collecting bag 1 is connected, at a first outletorifice 19, to a first end of a tube 20 communicating, through its otherend, with an inlet orifice 21 of a filter 22, in particular adeleukocyting filter, allowing the filtration of a whole blood or anerythrocyte concentrate. Filter 22 communicates through its outletorifice 23 with the first end of a tube 24 communicating, through itssecond end, with an inlet orifice 25 of a bag 26 for collecting thefiltrate. Collecting bag 1 is connected, at a second outlet orifice 27,to a first end of a tube 28 communicating, through its other end, withan inlet orifice 29 of a secondary collecting bag 30.

In one embodiment, the invention may employ:

a needle for collecting a biological fluid,

a collection container or bag for storing the collected biologicalfluid,

a first tubular member, such as a tubing, catheter, cannula, or conduitfor providing fluid communication between the needle and the collectioncontainer or bag for storing the collected biological fluid,

a collection container or bag for storing the collected biological fluidfor sampling,

a second tubular member, such as a tubing, catheter, cannula, or conduitfor providing fluid communication between the first tubular member andthe collection container or bag for storing the collected biologicalfluid for sampling, and

a clamp or valve for substantially irreversibly closing fluidcommunication in the first or second tubular member.

A description will now be given of one method of collecting blood from adonor using the system depicted in FIG. 1. In this method, twoirreversible closure devices 10 are initially open and reversibleclosure device 11 is closed. Blood is collected using needle 2 insertedinto the arm of a donor. Initially, the blood is sent into sampling bag6 by virtue of the closure of reversible closure device 11 which issituated on first tube 4 and downstream of Y junction 8. When samplingbag 6 is sufficiently filled, irreversible closure device 10 situated onsecond tube 7 is closed, and then reversible closure device 11 isopened.

The closure of irreversible closure device 10 on second tube 7eliminates a significant risk of faulty use which could consist, ifclosure device 10 were not irreversible, of opening it in order to sendall or some of the blood contained in sampling bag 6 to collecting bag1. Such manipulation might allow material caught in the initially drawnblood and secluded in sampling bag 6 to contaminate the blood incollecting bag 1. Additional problems and complications might alsoresult from such faulty use.

During, before or after the filling of collecting bag 1, the user cantake samples using sampling tubes and lateral sampling device 9. Forthis purpose, the user inserts the sampling tubes in a guide tube 9 a ofsampling device 9 and then, by vacuum the blood is sent from samplingbag 6 to the sampling tube via a sampling needle 9 b. One or moresampling tubes may be prepared and used to carry out tests on thecollected blood.

When collecting bag 1 is full, the user closes irreversible closuredevice 10 which is provided on first tube 4. The seal provided byirreversible closure device 10 is sufficient for the user not to beobliged to effect an immediate welding at the collecting location, whichpresents a significant economic advantage.

In addition, irreversible closure device 10 may be situated close to thevicinity of inlet orifice 5 of collecting bag 1 so as to eliminate orreduce the risk of coagulation in the tubes where anticoagulant is nolonger present.

By using instead the system depicted in FIG. 3, the blood collected canthen be treated in a conventional manner by centrifugation andfiltration so as to separate it into its various constituents. Red cellconcentrate may be collected in bag 26 and plasma or plasma constituentsmay be collected in bag 30 or in a system of bags including bag 30.

Although only exemplary embodiments of the invention are specificallydescribed above, it will be appreciated that modifications andvariations of the invention are possible without departing from thespirit and intended scope of the invention.

1. A container system for collection of a biological fluid comprising:i) a collecting device; ii) a collecting container; iii) a first channelproviding fluid communication between the collecting device and thecollecting container; iv) a sampling container; v) a second channelproviding fluid communication between the first channel and the samplingcontainer; and vi) at least one substantially irreversible closuredevice in an open position provided on at least one of the first andsecond channels, wherein the substantially irreversible closure device,once in a closed position, cannot readily be restored to an openposition and wherein the substantially irreversible closure devicecomprises: i) a lock base including: (a) a housing with two lateralclips to allow connection of the device to a tube and at least twointernal stops and an intermediate region between the two internalstops; and (b) an orifice; ii) a flange including: a) a projection thatpresses into the intermediate region between the two internal stops whenthe flange is closed over the lock base; and b) a finger with a radialtoe; and iii) a hinge around which the lock base and flange rotate withrespect to each other, whereby the lock base and flange may be rotatedaround the hinge to a closed position wherein the finger is disposedwithin the orifice and is secured therein by the radial toe.
 2. Thecontainer system of claim 1 wherein biological fluid comprises blood. 3.The container system of claim 1 wherein the collecting device comprisesa needle.
 4. The container system of claim 1 additionally comprising atleast one sampling device operably associated with the samplingcontainer.
 5. The container system of claim 1 wherein the substantiallyirreversible closure device is provided on the second channel.
 6. Thecontainer system of claim 1 wherein the substantially irreversibleclosure device is provided on the first channel.
 7. The container systemof claim 6 wherein the substantially irreversible closure device isprovided in close proximity to the collecting container.
 8. Thecontainer system of claim 1 wherein the system additionally comprises areversible closure device provided on the first channel.
 9. Thecontainer system of claim 1, wherein the substantially irreversibleclosure device comprises a locking structure and a flow-preventionstructure.
 10. The container system of claim 1, wherein thesubstantially irreversible closure device is made of polypropylene. 11.The container system of claim 1 whereby the system is operable tosubstantially irreversibly close fluid communication in at least one ofthe first and second channels by manipulation of the substantiallyirreversible closure device from the open position to a closed position.12. The container system of claim 1, wherein the substantiallyirreversible closure device, when closed, prevents fluid from flowingfrom the sampling container to the collecting container.
 13. Thecontainer system of claim 1, wherein the first channel comprises a firstand second tube.
 14. A container system for the collection of abiological fluid comprising: i) a means for collecting the biologicalfluid; ii) a means for storing the collected biological fluid; iii) afirst fluid communication means for providing fluid communicationbetween the means for collecting the biological fluid and the means forstoring the collected biological fluid; iv) a means for storinginitially collected biological fluid for sampling; v) a second fluidcommunication means for providing fluid communication between the firstfluid communication means and the means for storing initially collectedbiological fluid for sampling; and vi) at least one means in an openposition for substantially irreversible closure of fluid communicationin the first or second fluid communication means, wherein the means forsubstantially irreversible closure of fluid communication, once in aclosed position, cannot readily be restored to an open position; whereinthe means for substantially irreversible closure comprises: i) a lockbase including: (a) a housing with two lateral clips to allow connectionof the device to a tube and at least two internal stops and anintermediate region between the two internal stops; and (b) an orifice;ii) a flange including: a) a projection that presses into theintermediate region between the two internal stops when the flange isclosed over the lock base; and b) a finger with a radial toe; and iii) ahinge around which the lock base and flange rotate with respect to eachother, whereby the lock base and flange may be rotated around the hingeto a closed position wherein the finger is disposed within the orificeand is secured therein by the radial toe.
 15. The container system ofclaim 14, wherein the biological fluid comprises blood.
 16. Thecontainer system of claim 14, wherein the system additionally comprisesa means of sampling initially collected biological fluid.
 17. Thecontainer system of claim 14 additionally comprising at least one meansfor substantially irreversible closure of fluid communication in thefirst fluid communication means in close proximity to the means forstoring the collected fluid.
 18. The container system of claim 14wherein the system additionally comprises at least one means forreversible closure of fluid communication in the first fluidcommunication means.
 19. A container system for collection of abiological fluid comprising: i) a collecting device; ii) a collectingcontainer; iii) a first channel providing fluid communication betweenthe collecting device and the collecting container; iv) a samplingcontainer; v) a second channel providing fluid communication between thefirst channel and the sampling container; and vi) at least onesubstantially irreversible closure device in an open position providedon at least one of the first and second channels, wherein thesubstantially irreversible closure device comprises: a) a lock baseincluding: (1) a housing with two lateral clips to allow connection ofthe device to a tube and at least two internal stops and an intermediateregion between the two internal stops; and (2) an orifice; b) a flangeincluding: (1) a projection that presses into the intermediate regionbetween the two internal stops when the flange is closed over the lockbase; and (2) a finger with a radial toe; and c) a hinge around whichthe lock base and flange rotate with respect to each other, whereby thelock base and flange may be rotated around the hinge to a closedposition wherein the finger is disposed within the orifice and issecured therein by the radial toe.
 20. The container system of claim 19wherein the substantially irreversible closure device is made ofpolypropylene.
 21. The container system of claim 19 wherein biologicalfluid comprises blood.